A growing Neurology Biotech is seeking an established leader to join their Safety team as Senior Medical Director of Pharmacovigilance and Drug Safety. This leader will assume a central role in securing our Drug Safety and Pharmacovigilance capabilities, establishing a robust Medical Safety and Risk Management team, and overseeing the safety evaluation and benefit-risk management of our products across their entire span, from initial human trials to their post-marketing phase. Your strategic awareness will be instrumental in orchestrating safety monitoring strategies within our clinical development programs, both prior to and following product launches. An unwavering commitment to uphold, and ensure adherence to, all relevant US and international legal and regulatory standards pertaining to pharmacovigilance, signal detection, and risk management is essential.
The successful candidate will be at the forefront of the safety aspects for New Drug Application submissions, steering cross-functional Safety Management Teams. You will harness a culture of collaboration, liaising closely with experts across multiple disciplines, including Clinical Development, Clinical Operations and other various departments, ensuring an integrated, comprehensive approach to the company's drug safety management.
